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FDA Inspection
•UCSF Medical Center•January 19, 2018

UCSF Medical Center – FDA Inspection, Jan 19, 2018

Record Details

This FDA Inspection record concerns UCSF Medical Center, with an inspection on January 19, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
UCSF Medical Center
Inspection Date
January 19, 2018
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Roger D. Gawne (Company Rep)
View Company Profile

ID · 26121b20-b85b-40ec-906e-1e522291675e

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1038054
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 606.171Biological product deviation report

Full citation text and observation details available on the Dashboard.

Other FDA inspections of UCSF Medical Center

6
DateClassificationOfficeProject area
May 30, 2024NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 27, 2020NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
June 12, 2015VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
August 28, 2013NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 30, 2011NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
View all 6 other inspections on the company page
Other documents for UCSF Medical Center
  • FDA Inspection 1240573 - 2024-05-30
  • FDA Inspection 1122182 - 2020-02-27
  • FDA Inspection 929863 - 2015-06-12
  • FDA Inspection 846969 - 2013-08-28
  • FDA Inspection 747299 - 2011-09-30

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